Sanofi’s LixiLan meets target in Phase III diabetes trial
pharmafile | September 16, 2015 | News story | Research and Development | Lantus, LixiLan, Lixisenatide, Lxyumia, Sanofi, diabetes, insulin glargine, metformin, type 2 diabetes
Sanofi’s Phase III clinical trial of its Lixilan treatment has achieved its primary endpoint in patients with type 2 diabetes, as the firm readies itself for future regulatory filings.
LixiLan is a single-injection combination of Lyxumia (lixisenatide), a drug developed by Sanofi in collaboration with Danish company Zealand Pharma, and the French firm’s legacy blockbuster Lantus (insulin glargine).
The trials compared Lyxumia with insulin glargine 100 Units/ml, with or without metformin. The combination demonstrated a statistically superior reduction in HbA1c (average blood glucose over the previous three months). Sanofi says the fixed-ratio combination had a safety profile comparable to those of insulin glargine 100 Units/mL and the once-daily GLP-1 receptor agonist lixisenatide.
The Phase III trial investigated the efficacy and safety of LixiLan over a 30-week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents.
The trial continued treatment with metformin if patients had previously taken the medication, throughout the study. Sanofi said the results of this particular test will be communicated at a future conference.
Richard Bergenstal, executive director of the International Diabetes Center at Park Nicollet, Minneapolis, comments: “This study examined an important possible use of this investigational medicine. The result highlights that this could provide a treatment option for the roughly fifty percent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment.”
Sanofi previously announced in July 2015 that the previous LixiLan-O study met its primary objective over a 30-week period in 1,170 patients whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent.
The France-based drugmaker is targeting regulatory submissions for LixiLan for Q4 2015 in the US and Q1 2016 in the EU.
Joel Levy
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